REGiMMUNE
REGiMMUNE is a clinical-stage biotechnology company developing immune-regulatory therapeutics that modulate regulatory T cells using its proprietary reVax liposomal alpha-GalCer platform, targeting GvHD prevention, autoimmune disease, allergy, and oncology indications through licensing and pharmaceutical partnerships.
- Company typePrivate
- Founded2006
- HeadquartersTokyo, Japan
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What REGiMMUNE does
REGiMMUNE is a clinical-stage biotechnology company developing immune-regulatory therapeutics based on its proprietary reVax platform, which uses liposomal alpha-galactosylceramide (alpha-GalCer) formulations to pharmacologically induce regulatory T cells (Tregs) in an antigen-specific manner. Founded in 2006 and originating from technology exclusively licensed from Japan's RIKEN research institute, the company pursues a dual-modality strategy: enhancing Tregs to induce immune tolerance in transplantation (GvHD prevention), autoimmune disease, and allergy; and suppressing tumor-infiltrating Tregs to enable anti-tumor immunity in oncology. Its lead clinical asset, RGI-2001 (ToleroVax), is a liposomal formulation of KRN7000 that has completed a US Phase IIb trial for prevention of Graft-versus-Host Disease following allogeneic hematopoietic stem cell transplantation and has received FDA Orphan Drug Designation. The pipeline additionally includes antibody candidates RGI-Ab01 (Treg-targeting), RGI-Ab02 (checkpoint inhibitor), RGI-6004 (afucosylated anti-GARP/Latent-TGFb1), and AB08-H1 (anti-pan-MHC II for lymphoid malignancies and solid tumors).
The company is pre-commercial and generates revenue exclusively through licensing fees, upfront and milestone payments, and research funding from collaboration agreements rather than product sales. Distribution is achieved through pharmaceutical partnerships: a 2009 vaccine collaboration with Astellas Pharma, a 2015 JDRF/Pfizer collaboration for Type 1 Diabetes, and a 2023 license to San Fu Biotech for RGI-2001 development and commercialization across major Asian countries excluding Japan. The company has raised approximately $35-40M cumulatively across Series B through Series E equity rounds, plus a $12M grant from the Japan Science and Technology Agency in 2008, with its last disclosed funding round occurring in 2017. Operating geographies span Japan, Taiwan (where the company has shifted its operational headquarters), and the United States (US clinical operations), with preparations underway for a listing on Taiwan's Emerging Stock Market.
REGiMMUNE firmographics
Firmographics- Name
- REGiMMUNE
- Legal name
- REGiMMUNE Co, Ltd.
- Website
- https://regimmune.com
- Company type
- Private
- Founded year
- 2006
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- REGiMMUNE is a clinical-stage biotechnology company developing immune-regulatory therapeutics that modulate regulatory T cells using its proprietary reVax liposomal alpha-GalCer platform, targeting GvHD prevention, autoimmune disease, allergy, and oncology indications through licensing and pharmaceutical partnerships.
- Ownership category
- akta.pro rank
REGiMMUNE industry classification
Industry- Product category
- Immuno-modulatory Biopharmaceuticals
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Transplant & Immunosuppression Specialty Pharmaceuticals (HLAIACAJ)
- akta.pro secondary industries
- Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA), Transplantation & Advanced Therapies Pharmaceuticals (incl. Cell & Gene Therapies) (HLAIAAAO)
Keywords
Where REGiMMUNE is headquartered
LocationHeadquarters
- HQ city
- Tokyo
- HQ country
- Japan
- HQ region
- Asia
Offices2 records
Markets served
REGiMMUNE business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Licensing and Sublicensing: REGiMMUNE generates revenue through exclusive licensing agreements for its technology platforms and product candidates. The company has licensed rights to RIKEN's immune regulating technology and sublicenses its own products to partners like San Fu Biotech for major Asian countries.
- Collaboration and Partnership Agreements: Strategic collaborations with pharmaceutical companies including Astellas for vaccine technology and JDRF/Pfizer for Type 1 Diabetes research. These partnerships typically include upfront payments, research funding, milestone payments, and royalties.
- Equity Financing: The company has raised multiple equity financing rounds including Series B ($8M in 2008), Series C ($5M in 2012), Series D ($9.2M in 2014), and Series E ($6M in 2017) to fund clinical development.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
REGiMMUNE product offering
Product offeringCore offering
REGiMMUNE is a clinical-stage biopharmaceutical company developing immune-regulatory therapeutics based on its proprietary reVax platform, which induces regulatory T cells (Tregs) to establish antigen-specific immune tolerance. Its lead candidate, RGI-2001 (ToleroVax), targets Graft-versus-Host Disease (GvHD) prevention in hematopoietic stem cell transplantation and has completed Phase IIb clinical trials with FDA Orphan Drug Designation. The pipeline also includes antibody therapeutics (RGI-Ab01, RGI-Ab02, RGI-6004, AB08-H1) addressing cancer, autoimmune disease, allergy, and type 1 diabetes indications.
Product overview
REGiMMUNE is a clinical-stage biopharmaceutical company developing immune regulatory therapeutics based on its proprietary reVax platform technology. The company's portfolio includes RGI-2001 (ToleroVax), a first-in-class Treg-inducing agent for GvHD prevention that has completed Phase IIb trials, alongside an antibody therapeutics pipeline featuring RGI-Ab01 (Treg silencing), RGI-Ab02 (checkpoint inhibitor), RGI-6004 (Treg depleting antibody), and AB08-H1 (anti-MHC II antibody for cancer). The reVax platform enables antigen-specific immune tolerance through Treg induction, supporting products across allergy, autoimmune diseases, transplantation, and oncology.
Differentiator
Problem solved
Functional benefit
Brands
- RGI-2001: Lead product candidate - liposomal formulation of alpha-GalCer for GvHD treatment
- reVax
- ToleroVax
- RGI-1000 series
- RGI-3100 series
- RGI-4000 series
Products and services
- RGI-2001 (ToleroVax) Liposomal formulation of alpha-GalCer (KRN7000) that induces regulatory T cells to prevent Graft-versus-Host Disease following allogeneic hematopoietic stem cell transplantation. Lead clinical-stage product candidate with FDA Orphan Drug Designation granted October 2012.
- RGI-Ab01 Potent, high affinity-binding antibody targeting a protein specifically expressed on Tregs in the tumor microenvironment. Designed for tumor microenvironment biology with greater potency, high tumor tissue penetration, attractive pharmacokinetics, and low toxicities without systemic Treg depletion. Currently in late discovery stage.
- RGI-Ab02 Novel checkpoint inhibitor antibody binding to an inhibitory receptor expressed on CD8+ Effector T cells and NK cells. Designed for efficacy as monotherapy or in combination with anti-PD-1 therapies and other internal antibody products. Currently in early discovery.
- RGI-6004 Fully human afucosylated IgG1 antibody targeting the GARP/Latent-TGFb1 complex, designed to selectively deplete activated tumor-infiltrating Treg cells while leaving effector T cells intact. Demonstrated approximately 10 pM efficacy with minimal impact on platelets and hematological profile. Currently in preclinical/IND-enabling stage.
- AB08-H1 Humanized IgG antibody targeting pan MHC II (HLA II) that induces cancer cell lysis through homotypic aggregation and lysosomal membrane permeabilization without ADCC or CDC mechanisms. Being developed for lymphoid malignancies (Hodgkin and Non-Hodgkin lymphomas) and solid cancers expressing MHC II.
Quantifiable outcome
- Phase I/IIa study showed RGI-2001 was well-tolerated with no safety concerns up to highest dose; patients showed markedly increased Treg numbers within 1-3 weeks after HCT
- +3 more outcomes
Companies that use REGiMMUNE
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles3 records
REGiMMUNE technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
REGiMMUNE partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered major and core.
- San Fu BiotechmajorLicense agreement for development and commercialization of RGI-2001 in major Asian countries.REGiMMUNE signed underwriting contract with HuaNan Securities for Taiwan market entry.
- JDRF and Pfizer Inc.majorCollaboration for Type 1 Diabetes Prevention and Treatment research promoting regulatory T-cells. Three-way partnership leveraging REGiMMUNE's Treg technology with JDRF funding and Pfizer expertise.
- Astellas Pharma Inc.majorCollaboration to jointly research and develop a novel vaccine-platform technology. Partnership combines Astellas' screening and natural source-derived compound development capabilities with REGiMMUNE's immune liposome technology. Terms undisclosed.
- RIKENcoreExclusive license agreement granting REGiMMUNE the right to market/sublicense pharmaceutical products based on RIKEN's immune regulating technology.
Scale indicators7 records
Recent moves10 records
Expansion highlights6 records
REGiMMUNE competitors and assessment
Company assessmentEmerging players
- Cellectis: Clinical-stage gene and cell therapy company with engineered immune cell platforms including Treg engineering programs. Comparable as a clinical-stage Treg/cell therapy developer with overlapping immunology and oncology focus.
- Innovent Biologics: China-based biopharmaceutical company developing immuno-oncology biologics including antibodies targeting tumor microenvironment. Comparable on oncology antibody pipeline adjacent to REGiMMUNE's RGI-Ab01 and RGI-6004 programs.
Direct peers
- Quell Therapeutics: Develops engineered Treg cell therapies focused on organ transplantation and autoimmune diseases. Directly comparable in target indication (solid organ transplant tolerance) and Treg-modality approach to REGiMMUNE's RGI-2001.
- Kyverna Therapeutics: Clinical-stage cell therapy company developing Treg-based therapies for autoimmune diseases. Comparable Treg-modality platform with overlapping autoimmune indications.
- Sonoma Biotherapeutics: Clinical-stage biotech developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. Directly comparable to REGiMMUNE on Treg-modulation approach and target indications (autoimmune, transplant tolerance).
- Abata Therapeutics: Treg cell therapy company focused on autoimmune diseases, particularly progressive multiple sclerosis. Directly comparable on Treg-based approach and immune tolerance induction strategy.
- GentiBio: Engineered Treg cell therapy company targeting autoimmune and inflammatory diseases. Directly comparable on Treg platform technology and autoimmune disease indications overlapping with REGiMMUNE's pipeline.
Broad incumbents
- Pfizer: Global pharmaceutical company with active Treg-related research through the JDRF/Pfizer/REGiMMUNE Type 1 Diabetes collaboration and broad immunology pipeline. Relevant as a partner and large-cap incumbent in the immune-regulation space.
- Bristol Myers Squibb: Large pharmaceutical company with established immunology franchise including transplant immunosuppression (Nulojix/belatacept) and active Treg-related research. Represents both a potential BD partner and competitive threat in transplant/autoimmune indications.
- Astellas Pharma: Japanese pharmaceutical company with active cell and gene therapy programs and an existing vaccine-platform collaboration with REGiMMUNE (announced 2009). Comparable as both a strategic partner and a broader incumbent in transplantation and immune-regulation.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks7 records
Key highlights6 records
Customer concentration
REGiMMUNE social profiles
Digital presenceREGiMMUNE financial estimates
Financial estimateRevenue estimate
Valuation estimate
REGiMMUNE leadership team
Management profileNumber of profiles
Profiles6 records
REGiMMUNE subsidiaries and ownership
Company hierarchySubsidiaries1 record
REGiMMUNE funding detail
Funding detailFunding overview
Funding rounds9 records
Investors29 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
REGiMMUNE M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about REGiMMUNE
What does REGiMMUNE do?
REGiMMUNE is a clinical-stage biopharmaceutical company developing immune-regulatory therapeutics based on its proprietary reVax platform, which induces regulatory T cells (Tregs) to establish antigen-specific immune tolerance. Its lead candidate, RGI-2001 (ToleroVax), targets Graft-versus-Host Disease (GvHD) prevention in hematopoietic stem cell transplantation and has completed Phase IIb clinical trials with FDA Orphan Drug Designation. The pipeline also includes antibody therapeutics (RGI-Ab01, RGI-Ab02, RGI-6004, AB08-H1) addressing cancer, autoimmune disease, allergy, and type 1 diabetes indications.
Is REGiMMUNE a public or private company?
REGiMMUNE is a private company. It is classified as venture growth investor backed and is currently operating.
When was REGiMMUNE founded?
REGiMMUNE was founded in 2006. It employs 1 to 10 people.
Where is REGiMMUNE based?
REGiMMUNE is headquartered in Tokyo, Japan, in the Asia region.
How does REGiMMUNE make money?
Three revenue lines are on record. Licensing and Sublicensing is the primary driver. The others are collaboration and Partnership Agreements and equity Financing.
Who are REGiMMUNE's main competitors?
Emerging players on record are Cellectis and Innovent Biologics. Direct peers are Quell Therapeutics, Kyverna Therapeutics, Sonoma Biotherapeutics, Abata Therapeutics and GentiBio. Broad incumbents are Pfizer, Bristol Myers Squibb and Astellas Pharma.
Does REGiMMUNE have an API?
No public API is recorded for REGiMMUNE.
What industry is REGiMMUNE in?
REGiMMUNE's product category is Immuno-modulatory Biopharmaceuticals. Its primary akta.pro industry code is HLAIACAJ, Transplant & Immunosuppression Specialty Pharmaceuticals, with a secondary code of HLAAAGAL, Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics). Its NAICS code is 325414 and its SIC code is 2836.